Increased axial load carrying sheathed irrigating balloon catheter

ABSTRACT

A sheathed tubular semi-rigid balloon catheter for performing probing, irrigation, dilation, suction and potential intubation of the nasolacrimal system or paranasal sinus system to treat for stenosis or obstruction. The catheter includes a sheathed tubular probe portion through which a tracer fluid can be injected and through which suctioning of blood or other material can be conducted. The sheath portion of the device can have a distal segment that is inflated in order to dilate parts the nasolacrimal or paranasal sinus system. The high axial load accommodating catheter tool includes a more secure and inexpensively manufactured bond between the metallic semi-rigid tube of the probe portion and the plastic hand-manipulable, multi-connector hub using an enlarged bonding collar.

PRIOR APPLICATIONS

This is a continuation of U.S. patent application Ser. No. 15/997,586,filed 2018 Jun. 4, now U.S. patent Ser. No. 11/045,214, which is acontinuation-in-part of U.S. patent application Ser. No. 14/520,052,filed 2014 Oct. 21, which is a continuation of U.S. patent applicationSer. No. 12/831,133, filed 2010 Jul. 6, now U.S. Pat. No. 8,864,746,which is a continuation of U.S. patent application Ser. No. 11/441,558,filed 2006 May 26 abandoned. U.S. patent application Ser. No.15/997,586, filed 2018 Jun. 4, now U.S. patent Ser. No. 11/045,214 isalso a continuation of U.S. patent application Ser. No. 14/606,922,filed 2015 Jan. 27, now U.S. Pat. No. 9,987,025 which is acontinuation-in-part of U.S. patent application Ser. No. 12/302,269,filed 2009 Mar. 25, a US entry of International Patent ApplicationSerial No. PCT/US2007/012461, filed 2007 May 25, which is acontinuation-in-part of U.S. patent application Ser. No. 11/441,558,filed 2006 May 26, abandoned, and a continuation-in-part of U.S. patentapplication Ser. No. 11/473,445, filed 2006 Jun. 23, abandoned.

FIELD OF THE INVENTION

The present invention relates to devices used for normalizing the flowof fluid in the narrow complexly-shaped body cavities including thelacrimal drainage system and the paranasal sinus system. Morespecifically, the invention relates to probes, catheters, stents anddrainage tubes used in treating canalicular and nasolacrimal duct ornasal sinus obstruction caused by stenosis, lacerations or other trauma.

BACKGROUND

Rigid balloon catheters have been used to treat nasolacrimal andparanasal sinus obstructions as disclosed in my U.S. Pat. Nos. 7,169,163and 8,317,816 respectively. Physical obstruction problems occurring inthe lacrimal drainage system can be treated using a dual conduitirrigating and suctioning lacrimal catheter, having a dilatation balloonas disclosed in my U.S. Patent Application Publication No. 20090204142,incorporated herein by reference. Such catheters can be used to performballoon catheter dacryocystoplasty (DCP) and dacryocystorhinostomy (DCR)both translacrimally and transnasally.

The above dual conduit catheter can be formed by a semirigid stainlesssteel hypotube coaxially penetrating through the sidewall and into thecentral lumen of a diametrically slightly oversized flexible plastictube having a reduced thickness distal portion which can inflate as adilatation or anchoring balloon. The hypotube can be connected at itsproximal end to an irrigation or suction supply while the proximal endof the flexible tube can be connected to a compressed fluid ballooninflation supply.

As shown in Gould et al., U.S. Pat. No. 4,572,186, a V-shaped adapterassembly, also known as a hub, can secure the proximal ends of twocatheter conduits in a single, hand-graspable structure.

Because a dual conduit catheter can be subjected to relatively largeaxial forces during insertion through or around obstructions or otherbarrier structures, unwanted slippage can occur between the variousstructures such as between a hypotube and portions of the flexible tubeand/or hub, thus breaking the catheter and/or making it difficult forthe surgeon to properly manipulate and place the catheter in the body.It has been found that axial forces of 10 Newtons run the risk ofbreaking the above catheter designs.

The instant invention results from attempts to avoid some or all of theabove disadvantages.

SUMMARY

The principal and secondary objects of the invention are to provide formore efficient, simpler and safer procedures in the treatment ofnasolacrimal obstructions and/or paranasal sinus obstructions. These andother objects are achieved by a sheathed tubular elongated semi-rigidballoon catheter tool including a bonding collar securing the probeportion to a hub.

In some embodiments, there is provided a device for the treatment of anobstruction in a patient's lacrimal drainage system which comprises: anoblong probe portion shaped and dimensioned to axially penetrate thelacrimal system of a patient; wherein said probe portion furthercomprises: an elongated substantially cylindrical body having a firstouter diameter and terminating at a distal extremity and an oppositeproximal extremity; said body being made from a hard, semirigid firstmaterial; a collar bonded to a portion of said body near said proximalextremity; said collar being made from a hard, semirigid secondmaterial; said collar having an outer peripheral surface having a seconddiameter greater than said first outer diameter; and, a hand graspablehub comprising a second rigid material different from said firstmaterial, said hub being secured to said outer peripheral surface alonga hub/collar interfacing bond.

In some embodiments said hub/collar interfacing bond comprises aninterface layer contacting said collar and said hub.

In some embodiments said interfacing bond further comprises a proximalbead axially bearing against said collar.

In some embodiments said hub/collar interfacing bond is capable ofwithstanding an axial sheer load in excess of 10 Newtons.

In some embodiments said outer peripheral surface comprises a surfacearea increasing structure.

In some embodiments said surface area increasing structure comprises abearing surface having an axial component.

In some embodiments said outer peripheral surface of said collar isshaped to have a plurality of radial irregularities.

In some embodiments said radial irregularities comprise a plurality ofaxially spaced apart grooves.

In some embodiments said second diameter is at least twice as large assaid first diameter.

In some embodiments said collar has a volume of at least ten times thevolume of tube material within an axial zone of contact between saidbody and said collar.

In some embodiments said hub/collar interface comprises an amount ofsecondarily injected material contacting said hub and said collar.

In some embodiments said device further comprises: a flexible sheathcoaxially engaged by said body; wherein said sheath comprises: aproximal end portion secured to said hub; and, a distal end portioncomprising a balloon structure.

In some embodiments said device further comprises said body having anaxial lumen extending from a proximal opening to a distal port.

In some embodiments said hub comprises: a first connector leading to afirst passageway in fluid communication with said distal port; a secondconnector leading to a second passageway in fluid communication withsaid balloon structure.

In some embodiments said device further comprises an irrigation deviceor a suction device connected to said first connector.

In some embodiments said device further comprises an inflating deviceconnected to said second connector.

In some embodiments said sheath has an axial length shorter than anaxial length of said body.

In some embodiments said sheath is shaped and dimensioned to provide agap between an outer surface of said body and an inner surface of saidsheath.

In some embodiments said gap is formed by a fluid supplied to saidsecond connector a pressure sufficient to deform said sheath.

In some embodiments said sheath comprises an expandable materialselected to allow a compressed fluid to pass through said gap andinflate said balloon structure.

In some embodiments said balloon structure comprises a segment of saidsheath having a reduced wall thickness along said segment.

In some embodiments said body further comprises: said distal extremitybeing blunted; and, said body having a total length betweenapproximately 4 and 50 centimeters and an outer diameter between 0.125and 5.0 millimeters.

In some embodiments said first material is taken from a group consistingof: stainless steel, bronze, silver, aluminum, titanium, brass, andalloy thereof, Kevlar, Nitinol, polymide, Dacron, nylon, EPTFE,polycarbonate, and PVC.

In some embodiments said first material comprises plastic or metal.

In some embodiments said first material and said second material are thesame.

In some embodiments said probe portion has a maximum cross-sectionaldimension of between about 1.0 millimeter and 4.0 millimeters.

In some embodiments said device further comprises an elongatedreinforcing rod shaped and dimensioned to be inserted into said lumen.

In some embodiments said reinforcing rod is further shaped to have asemicircular cross-section, thereby forming an axial groove extending anentire length of said rod; said groove being sized to accommodatepassage of a fiberoptic cable therethrough.

In some embodiments there is provided a method for manufacturing aballoon catheterization tool, said method comprises: separately forminga plastic hub; and a metal collared, elongated semi-rigid tubular bodycovered by flexible sheath; inserting the collared probe body into apassageway of the hub; injecting a liquid bonding material through anaperture in the hub surrounding the collar in enough quantity to contactboth said hub and said collar; and, allowing said bond material tosolidify.

In some embodiments there is provided a method for probing the integrityof a patient's canaliculus and nasolacrimal duct which comprises thesteps of: inserting the device of claim 1 through the patient's punctumand canaliculus down the lacrimal sac; tilting the device angularly intoalignment with the nasolacrimal duct; and, pushing the device throughthe nasolacrimal duct down to the nasal cavity; wherein said pushingcomprises applying an axial force in excess of 10 Newtons to said hub.

In some embodiments said method further comprises engaging a stiffeningrod diametrically sized to engage said lumen and having a length greaterthan said total length into said lumen prior to said step of inserting.

In some embodiments said method further comprises engaging a stiffeningrod diametrically sized to engage said lumen and having a length shorterthan said total length into said lumen prior to said step of inserting.

In some embodiments said method further comprises injecting anirrigation or tracer fluid through said device while said device isengaged in said patient's lacrimal system.

In some embodiments said method further comprises suctioning materialthrough said device while said device is engaged in said patient'slacrimal system.

In some embodiments there is provided that in a semirigid ballooncatheter tool including an oblong semirigid hollow tube having an axiallumen extending between a proximal opening and a distal port; animprovement which comprises: a reinforcing rod shaped to penetrate saidlumen; said rod having a semicircular cross-section, thereby forming anaxial groove extending an entire length of said rod; said groove beingsized to accommodate passage of a fiberoptic cable therethrough.

In some embodiments there is provided a method for transnasally dilatinga small, tight opening through human tissue into the nasal cavity whichcomprises the steps of: inserting transnasally the device of claim 27toward a small, tight opening through human tissue into the nasalcavity; pushing the device through said opening until said balloonstructure engages said opening; wherein said pushing comprises applyingan axial force in excess of 10 Newtons to said hub; and, inflating saidballoon structure.

In some embodiments said opening consists of an ostium or surgicallyprepared opening in the sphenoid sinus.

In some embodiments said opening consists of an ostium or surgicallyprepared opening in the maxillary sinus.

In some embodiments said opening consists of an ostium or surgicallyprepared opening in the frontal sinus.

In some embodiments said method further comprises plastically deformingsaid device prior to said inserting.

In some embodiments said plastically deforming is conducted according toa shape derived from a shaping rod previously inserted transnasally intosaid opening.

In some embodiments said plastically deforming comprises bending saidprobe portion to an angle of between about −90 and +160 degrees.

In some embodiments said method further comprises engaging a fiberopticcable through an axial groove in said reinforcing rod.

In some embodiments said method further comprises injecting anirrigation or tracer fluid through said device while said device isengaged in said opening.

In some embodiments said method further comprises suctioning materialthrough said device while said device is engaged in said opening.

In some embodiments there is provided a device for transnasally dilatinga small, tight opening through human tissue into the nasal cavity, saiddevice comprising: a tubular body having a proximal extremity, aproximal segment, a distal extremity, and a distal segment and a centrallumen; a reinforcing rod element shaped to penetrate said lumen; aflexible sheath coaxially engaged by said body; an inflatable memberformed on said sheath proximate to said distal segment; said inflatablemember being capable of dilating said opening; wherein said tubular bodylacks sufficient stiffness and column strength in absence of saidreinforcing rod element inserted through said central lumen, to enablesaid inflatable member, when said inflatable member is deflated, to beinserted transnasally through the naris and into a nasal cavity andsubsequently pushed through forces applied on said proximal segment intosaid opening; and wherein said tubular body has sufficient stiffness andcolumn strength while said reinforcing rod element is inserted throughsaid central lumen, to enable said inflatable member, when saidinflatable member is deflated, to be inserted transnasally through thenaris and into a nasal cavity and subsequently pushed through forcesapplied on said proximal segment into said opening; and, wherein saiddistal end is separated from said proximal end a distance sufficient toallow said proximal end to remain outside the nasal cavity while saidinflatable member is being pushed into said opening.

The text of the original claims below is incorporated herein byreference as describing features in some embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a diagrammatic cross-sectional side view, including partialenlarged views, of an irrigating/suctioning sheathed tubular ballooncatheter including a hub bonding collar according to an exemplaryembodiment of the invention.

FIG. 2 is a diagrammatic cross-sectional end view the tube and sleevetaken along line 2-2 of FIG. 1.

FIG. 3 is a diagrammatic cross-sectional end view the tube and sleevetaken along the probe portion showing a friction fitted sleeve.

FIG. 4 is a diagrammatic cross-sectional end view a combination of thecollared tube and hub taken along line 4-4 of FIG. 1.

FIG. 5 is a diagrammatic cross-sectional enlarged side view showing thesheer forces on the hub bonded collar.

FIG. 6 is a diagrammatical flow chart of assembly steps to form thesheathed probe of FIG. 1.

FIG. 7 is a diagrammatical illustration of the use of the tool in a DCPprocedure.

FIG. 8 is a diagrammatical illustration of the use of the tool in atranslacrimal DCR procedure.

FIG. 9 is a diagrammatical illustration of the use of the tool in atransnasal DCR procedure.

FIG. 10 is a diagrammatic cross-sectional side view, including partialenlarged views, of an irrigating/suctioning sheathed tubular ballooncatheter including a hub bonding collar according to an alternateexemplary embodiment of the invention.

FIG. 11 is a diagrammatic cross-sectional end view the reinforcing rod,its connector and an inserted LED light source cable taken along line11-11 of FIG. 10.

FIG. 12 is a diagrammatic cross-sectional end view of an alternateembodiment of an alternate reinforcing rod having a roundedcrescent-shaped cross-section, its connector and an inserted LED lightsource cable having a circular cross-section.

FIG. 13 is a diagrammatical illustration of the use of the tool in asphenoid sinus opening dilatation procedure.

FIG. 14 is a diagrammatical illustration of the use of the tool in amaxillary sinus opening dilatation procedure.

FIG. 15 is a diagrammatical illustration of the use of the tool in afrontal sinus opening dilatation procedure.

DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

The present exemplary embodiment will be described as it relates totreating a lacrimal obstruction. Modifications described further belowcan adapt the disclosed tool to treating some paranasal sinusobstructions.

Referring now to the drawing, there is shown in FIGS. 1 and 2, amulti-functional surgical tool 31 for the treatment of nasolacrimalobstructions. The tool includes an elongated, hollow, semi-rigid probeportion 20 having a distal, inflatable balloon 37. The probe portionconnects at a proximal end to a rigid hub 50 which can be readilygrasped by the hand of the surgeon to manipulate the tool. The hub alsoincludes one or more openings for connecting supplies of pressurizedfluid or suction.

The probe portion 20 is shaped and dimensioned for insertion through apatient's punctum and canaliculus, into the lacrimal sac and potentiallythrough the lacrimal sac into the nasolacrimal duct, or through themedial wall of the lacrimal sac into the nasal cavity. The totalcross-sectional diameter A of the uninflated probe portion can thereforehave a maximum dimension of between about 0.25 and 10 millimeters, andtypically about 1.0 millimeter for the present embodiment.

The probe portion 20 has enough rigidity to be maneuvered through thesoft tissue twists and turns of the nasolacrimal network, but isflexible enough to bend around the small curves of the network withoutsignificantly cutting into those tissues. Once the distal end of theprobe portion has passed through the obstruction, the balloon 37 can beinflated in vivo to dilate the tissue near the obstruction. Therefore,the probe must have a rigidity/flexibility and column strengthsufficient to be pushed axially through the obstruction. Thus the probeportion can have a stiffness and a column strength capable ofwithstanding axial forces without buckling in excess of 10 Newtons andup to 15 Newtons for smaller cross-section devices and up to 200 Newtonsfor larger cross-section devices. It should be understood that themechanical characteristics of the sheath do not appreciably contributeto the mechanical properties of flexibility and column strength of thesheathed probe tool. Thus it is primarily the mechanical characteristicsof the semi-rigid tube that determine the flexibility and columnstrength of the tool.

Because it is to be introduced into the body, the probe portion 20 canbe made of biocompatible materials.

The probe portion of the tool 20 includes an oblong, semi-rigid, tubularbody or tube 30 coaxially engaging and secured within the central axialchannel 43 of an oblong, flexible, tubular sheath 40. The balloon 37 canbe formed on a distal portion 39 of the sheath. A gap 49 between theinner surface of the sheath and the outer surface of the semi-rigid tubecan carry a pressurized fluid such as air to expand the balloon.

The tube 30 is shaped and dimensioned to have a substantiallycylindrical outer surface 36. The tube 30 can be in the form of aconduit, such as a stainless steel hypotube, having an axial lumen 33terminating at a proximal extremity 41 forming a proximal opening 34,and terminating at an opposite distal extremity 42 forming a distalaxial port 35. Fluids can be injected, or suctioned through the axiallumen 33 of the tube. The distal extremity can be blunted to help avoidtissue abrasion during insertion. Optionally, one or more radial ports28 can be formed through the sidewall of the probe, and if necessarythrough the sheath, and located a proximal distance from the axialdistal port 35. The radial ports can provide a fluid passageway shouldthe axial distal port be blocked.

The tube 30 can be made from material such as many stainless steels andother metals and alloys thereof such as titanium, silver, aluminum,bronze, brass, and synthetics like Kevlar, Nitinol, polymide, Dacron,nylon, EPTFE, polycarbonate or PVC may also be suitable. For manyapplications the probe can have an outer diameter ODt of between about0.5 millimeter (0.02 inch) and 2.5 millimeters (0.1 inch), but couldfall between about 0.1 millimeter (0.004 inch) and 6.0 millimeters (0.24inch) for more specialized purposes such as pushing the tool through themedial sac wall. The axial lumen 33 of the tube can have a diameter ofbetween about 0.001 millimeter (0.00004 inch) and 5.0 millimeters (0.2inch).

The tube 30 can coaxially secure along a part of its outer surface 36 tothe inner sidewall of the sheath 40. The sheath can have a proximalopening 47 at a proximal end 44 and a distal opening 45 at a distal end46 which can be sealed to the probe by an annular layer of adhesive 48.The tube can thus pass through both the proximal opening 47 of thesheath and the distal opening 45 of the sheath. The radial ports 28 canbe surrounded by adhesive 48 avoiding fluid communication between thelumen 33 of the tube and the axial channel 43 of the sheath.

The flexible sheath 40 includes a central axial channel 43 which can bedimensioned to be slightly diametrically oversized with respect to thetube so that there remains a gap 49 between the inner wall of the sheathand the outer wall of the tube so that a fluid injected into the sleevecan readily flow through the gap to fill the balloon. The gap canannularly surround the tube in which case a layer of adhesive 75 can beused to secure portions of the sheath to the tube. The adhesive can belocated at the distal end 46 and optionally near the proximal end 44.Alternately, as shown in FIG. 2, the gap can be formed along an angularzone 74 where there is an absence of the adhesive between the sheath andtube.

Alternately, as shown in FIG. 3, the sheath 71 can be sizedcommensurately with the outer surface 76 of the tube 72 so that theinterfacing surfaces of the tube and sheath intimately contact oneanother. The sheath can be retained on the tube by selecting the outerdiameter of the tube to be larger than the unstressed inner diameter ofthe sheath thereby causing a friction fit between them, keeping thesheath lodged and in a stabilized position relative to the tube. Thishelps secure the entire length of the sheath to the tube and provides asmooth outer surface to the tool, enhancing its ability to be readilypushed into place in the lacrimal drainage system. In this embodimentthe radially expanded gap 79 can be formed emobically under theinfluence of a pressurizing fluid 77. Thus the gap need not be annular,nor radially uniform but rather can be formed by a radial expansion ofthe resilient sheath material, and can occur at any angular locationdepending on the subtle weaknesses in the sheath material. Of course, inthis embodiment the sheath must be made from a deformable material sothat it can expand slightly under the force of the pressurized fluid.

The sheath can be made from a flexible, biocompatible synthetic materialsuch as nylon. It can also be made of polyethylene terephthalate (PET),silicone, latex, polyurethane, polyvinyl chloride, cross-linkedpolyethylene, polyolefins, HPTFE, HPE, HDPE, LDPE, EPTFE, and blockpolymers, and/or other biocompatible elastomeric materials andcombinations thereof. For most applications where nylon is the selectedsheath material, the thickness of the sheath can be between about 0.001millimeter (0.00004 inch) and about 5.0 millimeters (0.2 inch), and formost lacrimal obstruction treatment applications be about 0.15millimeters (0.006 inch)

Referring back to FIGS. 1-2, the balloon portion 37 can made of the samematerial as the rest of the sheath 40 so long as it is resilientlyexpandable. The balloon portion can have a reduced thickness from thatof the rest of the sheath, thus allowing it to expand relative to therest of the sheath when under the influence of an internal pressurizingfluid. Thus, the sheath 40 can have a first given thickness Ts in thenon-balloon portion and a second, reduced thickness TB along a distalportion 39 to form an expandable balloon 37. Thus, the thickness of theballoon can be between about 0.05 millimeter (0.002 inch) and 10millimeters (0.4 inch), and for most lacrimal obstruction treatmentapplications be about 0.10 millimeter (0.004 inch). The inflatableballoon can have an axial length 39 of between about 0.5 centimeter (0.2inch) and 5 centimeters (2.0 inches), and for the present embodimenttypically about 1.5 centimeters (0.6 inch). The balloon can be inflatedusing air pressures of between about 1.0 pound per square inch (psi)(0.7 atmosphere) and 30 psi (2.0 atmospheres) resulting in an inflatedcross-sectional diameter of between about 1.0 millimeter (0.04 inch) and20 millimeters (0.8 inch), and for most lacrimal obstruction treatmentapplications between about 2.0 millimeters (0.08 inch) and 6.0millimeters (0.25 inch). It has been found that such fluid pressures canalso adequately cause formation of an acceptable embolic gap between thetube and sheath leading from the hub to the balloon necessary in theembodiment of FIG. 3.

Alternatively, a balloon segment made of a more easily expanded materialcan be attached to the distal end of the sleeve.

Referring now primarily to FIG. 1, the rigid hub 50 can be secured overthe proximal extremity 41 of the tube 30 and the proximal end 44 of thesheath 40. The hub includes a first passageway 51 leading from a firstluer-lock or other type of connector 52 to the proximal opening 34 tothe tube 30, and a second passageway 53 leading from a second luer-lockor other type of connector 54 to the proximal opening 47 to the sheath40. The two passageways 52,54 are sealed from one another; and thusthere is no fluid communication path therebetween.

The sheath 40 can be secured to the hub 50 by a hollow cylindrical rigidplastic spacer 55 bonded by layers of adhesive (not shown in thedrawing) or other means known in the art. A flexible vinyl boot 56 sealsthe distal edge 57 of the hub to the outer surface of the sheathextending distally therefrom.

The hub 50 can be made from a durable, rigid, injection moldablematerial such as polycarbonate, or other plastics and stainless steel orother metals. When this material is different from the material of thesemi-rigid tube, it can have a higher coefficient of thermal expansionand a lower thermal conductivity than the material of the tube. Thismismatch in material properties can lead to weakness along a mechanicalbond between the tube and hub.

The total insertable length of the tool measured from the distal extentof the boot 56 to the distal extremity 42 of the tube 30 may be withinrange from between about 1 centimeter (0.4 inch) and 50 centimeters (20inches), and is typically about 15 centimeters (6 inches) for thepresent embodiment.

Referring to FIGS. 1, 4 and 5, the tube 30 can be secured to the hub 50through a rigid collar structure 60 welded to the cylindrical outersurface of the tube near its proximal extremity 41. The peripheral outersurface 64 of the collar is bonded to a corresponding inner surface ofthe hub's first passageway 51 along a hub/collar bond 65 for the tube byan adhering layer of adhesive 61 injected during assembly of the toolthrough an aperture 62 in the sidewall of the hub over the location ofthe collar. The adhering layer can be a secondarily injected amount ofthe same material that forms the hub. For example, the hub can be formedfrom a first injection molded amount of polycarbonate plastic, and theadhering layer can be formed from a subsequent, secondarily injectedamount of adhesive such as epoxy or molten plastic.

The bond 65 between the collar and the hub effectively seals the firstpassageway 51 of the hub over the proximal opening 34 to the tube 30.Optionally, the injection of an overabundance of bond material creates aproximal bead 66 of bond material bearing against a proximal facing edgeof the collar to further secure the collar and tube from being dislodgedby higher magnitude axial forces on the tube. In other words, theproximal bead of bond material 66 forms an axial barrier against which acollar bearing surface 67 bears. This axial barrier thus has an axialcomponent against which the collar bears, thereby allowing the tube towithstand larger axial mechanical load without breaking free from itsaxial position within the hub.

The collar has an outer diameter ODc which is at least twice as large asthe outer diameter of the tube OD_(T) and can be close to the innerdiameter of the hub passageway ID_(H). In this way the surface areaforming the bond between the collar and the hub is increased and thusstrengthened. Because the outer diameter of the collar is selected to beclose to the inner diameter of the hub passageway, the secondaryinjection of adhesive or hub material between these two surfaces is donein a controlled, localized manner allowing minor controlled adjustmentto the secondary injection pressure to adjust the size of the resultantproximal bead 66.

The outer surface of the collar can be shaped to have a number ofaxially spaced apart circumferential grooves 63, or otherwise roughenedthrough scoring or grit blasting for example, in order to form radialirregularities to further increase the available surface area and toform bearing surfaces which resist axial sheer forces, and thus forminga more rugged bond between the collar and the hub. These axial bearingsurfaces also form an axial barrier against which corresponding surfacesof the bond material bears.

It has been found that the collar-to-hub bond can, as a minimum for mostcommon nasolacrimal catheters, withstand an axial load F in excess of130 Newtons. This load is applied as a sheer force of the bond due tothe countering reactive force F′. In practice it has been found that thebond can often withstand a load in excess of 175 Newtons.

The coefficient of thermal expansion (“CTE”) or simply the thermalexpansion of a material is defined as the ratio of the change in lengthper degree Centigrade to the length at 25 degrees C. It is usually givenas an average value over a range of temperatures. The CTE of stainlesssteel is between about 10 ppm/degree C. and 17 ppm/degree C., whereaspolycarbonate is typically between about 65 ppm/degree C. and 70ppm/degree C. Therefore, polycarbonate expands far more than stainlesssteel under the influence of heat.

The thermal conductivity (“TC”) of a material its property to conductheat, and is measured in watts per meter kelvin. The TC of stainlesssteel is between about 16.3 W/(m·K) and 24 W/(m·K), whereaspolycarbonate is typically between about 0.19 W/(m·K) and 0.22 W/(m·K).Therefore, stainless steel is a far better thermal conductor thanpolycarbonate.

Although the increase in area of contact between the collar and hubcould be expected to improve the bond between them, the increase in sizeof the zone of contact will undergo larger stresses due to thermaldisplacement. In other words, as the bond interface grows in diameterthe bond will be subject to greater mechanical stress due to the thermalexpansion mismatch between the hub and collar, thus weakening the bond.Thus, merely increasing the surface area of the bond can be counterintuitive.

The warmth of the surrounding body tissues and the temperature of fluidscoursing through the catheter can also lead to thermal expansionmismatch stresses. For example, the warmth of the surgeon's fingers andsurgical lights on the hub may warm it more than the tube or collar,especially when colder fluids are injected. Further, the presence of thecollar reduces the amount of hub material surrounding the bonded zone ofcontact between the plastic and metal. Having less relatively insulatinghub material, having a relatively low coefficient of thermalconductivity, means the bond zone is warmed more quickly than it wouldhave been without the collar. This occurs during a time when the hub isbeing grasped hard by the surgeon while it is being pushed through theobstruction and thus subjected to its greatest axial load.

However, unexpectedly, it is believed that the increased heat sinkcapacity of the collar helps reduce the expansion mismatch at leasttemporarily because of the greater volume of material present. So, eventhough outer portions of the hub is being warmed, inner portions inclose contact with the collar are kept cooler. In addition, because ofthe higher TC of the tube relative to the hub, thermal energy is rapidlytransported to the collar, expanding it before the hub materialsurrounding the collar is heated.

Therefore, increasing the volume of material in the collar can increasethe heat sink effect. It has been found that the volume of material inthe collar can be least five times the volume of tube material within anaxial zone of contact between said tube and said collar. This zone ofcontact can correspond to the axial length L of the collar. Forcylindrical tube and collar shapes, the volume of collar material Vc canbe expressed thus:

Vc=L*Π[(ODc/2)²−(ODt/2)²]

And the volume of tube material Vt within an axial zone of contact canbe express thus:

Vt=L*Π[(ODt/2)²−(D _(L)/2)²]

For the present embodiment where the outer diameter of the tube ODt isbetween about 0.2 millimeter (0.008 inch) and 6.0 millimeters (0.24inch), and for most lacrimal obstruction treatment applications about0.5 millimeters (0.02 inch), the outer diameter of the collar ODc can bebetween about 0.5 millimeter (0.02 inch) and 20 millimeters (0.8 inch),and for most lacrimal obstruction treatment applications about 3.0millimeters (0.12 inch). The axial length of the collar can be betweenabout 0.1 millimeter (0.004 inch) and 25 millimeter (1 inch), and formost lacrimal obstruction treatment applications about 5 millimeters(0.2 inch). Those skilled in the art will readily appreciate the volumecalculations for most other shapes.

Referring now to FIG. 6 there is shown the primary manufacturing step ofsecondary injection of hub material. The hub and the collared tube,covered by a flexible sheath, are formed separately 91. The hub can beformed by a primary injection molding process. The tube can be formed bymeans well-known in the art. The distal extremity of the tube can beburnished at this time to form a rounded tip. The collar can be weldedto the tube near its proximal end. The tube can be inserted into theflexible sheath, and subjected to a heating process to shrink the sheathonto the tube to form the probe portion assembly. The probe portionassembly can be inserted into the passageway of the hub 92 and kept at aproper axial position with respect to the hub while a secondaryinjection molding process is conducted 93 to inject hardenable materialinto the passageway in intimate contact with both the collar and theinner surface of the hub passageway. The material can be an moltenplastic material similar to the material of the hub, epoxy glue, orother hardenable martial bondable to the hub material and the collarmaterial. The material is allowed to harden forming a bond between thecollared tube and the hub.

The above-described surgical tool can be used in a variety of surgicalinterventions as explained below.

Referring now to FIG. 7, in a balloon catheter DCP procedure, thesurgeon begins dilating the punctum with a punctual dilator beforeinserting the sheathed semi-rigid tube probe portion of the tool 31 in aballoon deflated state through the punctum 101 and canaliculus 102 downto the lacrimal sac 103. The probe portion can first be inserted througha punctum 104 in the upper or lower eyelid to help properly orient thetool to the lacrimal sac. A barrier is felt when the probe encountersthe medial lacrimal sac wall and lacrima fossa. The tool is thenretracted about 0.5 millimeters and is tilted about 90 degrees intoalignment with the nasolacrimal duct 105. The probe is then pushed downthe nasolacrimal duct and into the nasal cavity 106.

A syringe 110 can be connected directly to the connector 52 on the hub50 of the tool 31. Alternatively, the syringe can be connected via aflexible tube. The syringe can be loaded with fluorescein or methyleneblue stained fluid 111 or any other tracing fluid. The fluid is injectedto irrigate through the tube and into the nose. Traces of the fluid canbe recovered in the nose with a suction device 114. A lack of fluid inthe nose indicates that the tool has not penetrated all obstructions andreached the nose, or perhaps has taken a divergent passage throughtissues surrounding the nasolacrimal duct. The surgeon can then eitherpush with greater force or pull the tool slightly and drive it into thenasal cavity at a slightly different angle. Detection of the tracingfluid in the nose is a positive indication that all obstructions havebeen penetrated and the tool has followed a non-divergent path. Itshould be noted that the surgeon does not have to perform the difficultand sometime impossible task of touching the tip of the tool in the nosewith another metal instrument in order to confirm that the tool has dulyentered the nasal cavity.

While the tool remains emplaced, a pressurized fluid supply line 117 canbe connected to the sheath connector 104 at the proximal end of the toolhub 50. An inflating fluid is sent down the sheath to inflate theballoon 37 and dilate the stenotic nasolacrimal duct 105. If necessary,the balloon can deflated and pulled more proximally before a newinflation cycle is performed. The procedure can be repeated as manytimes as it may be necessary to dilate the entire duct and the sac-ductjunction. The balloon is deflated and withdrawn from the lacrimalsystem. A syringe having a cannula is inserted into the canaliculus, andirrigation with a tracer liquid can be made. If irrigation is notsuccessful the tool may be pushed back before repeating the inflationprocedure until tracer fluid recovery in the nose confirms that allobstructions have been corrected.

If significant bleeding occurs during the procedure, the syringe 110 canbe removed and the connector 52 is connected to the suction device inorder to remove the blood.

Although, it is the discretion of the surgeon to initially use astandard probe to verify the patency of the pathway from the punctumthrough to the nasal cavity, an advantage of using the sheathedsemi-rigid tube tool is that this initial step can be avoided. Thepatency can be verified by the probe portion of the tool during itsinitial insertion. Further, the entire procedure can be performed usingonly a single insertion of the tool. This helps reduce irritation orother damage to the tissues involved.

Referring now to FIG. 8, a balloon catheter DCR can be performed byinserting the probe portion of the tool 31 as described above inconnection with a DCP into the lacrimal sac. Optionally, a standardprobe may be pushed through one or more times to make sure there existsan opening. The probe portion of the tool is then pushed through theinferomedial wall of the sac, lacrimal fossa, and lateral nasal wall 126into the nose. The distal end of the tool can be visualizedendoscopically, or a syringe can be connected to the connector 52 toinject a tracer fluid through the probe 30 of the tool. The presence oftracer fluid in the nose confirms the distal end of the tool is in thenasal cavity. The tool can be further pushed through multiple adjacentareas to enlarge the opening and push bone chips of lacrimal fossa boneand possibly ethmoid bone into the nasal cavity. Theirrigation/confirmation step can be repeated. The syringe can then bereplaced by the suction device, and blood and tissue debris suctioned.Bleeding is usually more profuse than in a DCP and suctioning may haveto be performed during the entire operation.

Inflation of the balloon 37 is accomplished by connecting the sheathconnector 54 to an inflation device as described earlier. Balloondilatation of the area about the opening into the inferomedial wall 126completes the operation. The tool in then withdrawn.

As shown in FIG. 9, the performance of a transnasal balloon catheter DCRcan be performed basically in the same manner as the above-describedtrans-lacrimal DCR, except that after probing and piercing of theinferomedial wall and lateral nasal wall, a modified transnasalembodiment tool 131 can be brought up through the external naris, up thenasal cavity 132 and pushed through the opening in the lateral nasalwall, lacrimal fossa, and inferomedial wall 126 and into the lacrimalsac 103.

The modified tool 131 has a distal segment 129 bent at an angle ofbetween about 10 and 170 degrees, and is typically about 90 degrees. Thetransnasal embodiment tool has a generally larger diameter to make thetool stiffer in order to accommodate the larger lateral forces requiredto insert the bent portion through the opening.

A suction procedure can be performed through the probe 130, and then adilatation procedure as described above. After disconnecting the suctiondevice, irrigation may be performed.

The tubular probe 131 can also be used at that time to delivermedications into the nasolacrimal duct.

The entire tool 131 including its sheath can be removed, whereupon thesurgeon can insert a short cannula of about 1.0 centimeter in lengthinto the punctum and canaliculus. With syringe, a tracer fluid can thenbe injected through the cannula into the nasolacrimal network. If noneof the fluid is recovered in the nose, the procedure must be repeated.

In lieu of a tracer fluid, a radio-opaque or isotopic solution can beinjected. An x-ray or radiation detecting machine can then be used toconfirm the proper penetration of the tool.

It can thus be understood that the flexibly sheathed semi-rigid tubeprobe of the invention is a very versatile instrument that can be usednot only for probing the nasolacrimal ducts, but also to performintubation, irrigation and even suction of obstructive material.

In this way a surgeon can confidently apply an axial force of greaterthan 100 Newtons to a balloon carrying sheathed irrigating semi-rigidprobe in attempting to overcome blockages.

Nasal Sinus Embodiments

The sheathed tubular elongated semi-rigid balloon catheter tool can alsobe used in the treatment of obstructions in the paranasal sinuses.

Referring now to FIGS. 10 and 11, there is shown an alternate exemplaryembodiment of a multi-functional surgical tool 131 for the treatment ofparanasal sinus obstructions. The tool includes an elongated, hollow,semi-rigid probe portion 120 having a distal, inflatable balloon 137.The probe portion connects at a proximal end to a rigid hub 150 whichcan be readily grasped by the hand of the surgeon to manipulate thetool. The hub also includes one or more openings for connecting suppliesof pressurized fluid or suction. A hollow stiffening rod 170 coaxiallyengages the lumen of the tube to adjust its mechanical properties.

The probe portion 120 is shaped and dimensioned for insertion through apatient's nasal cavity and to be pushed through a stenotic or otherwiseobstructed paranasal sinus ostium or surgical opening. The totalcross-sectional diameter B of the uninflated probe portion can thereforehave a maximum dimension of between about 0.25 millimeter (0.01 inch)and 10 millimeters (0.4 inch), and typically about 2.0 millimeters (0.08inch) for the present embodiment. Once the distal end of the probeportion has passed through the obstruction, the balloon 37 can beinflated in vivo to dilate the tissue near the obstruction.

In this embodiment the probe portion 120 need not have enough columnstrength or stiffness to be pushed through a stenotic or otherwiseobstructed paranasal sinus ostium or surgical opening but rather can bereceive a stiffening rod to achieve a stiffness and column strengthappropriate for the particular region or condition being probed.Therefore, only with the reinforcing rod inserted can the probe portioncan have a rigidity/flexibility and column strength sufficient to bepushed axially through the obstruction. Thus the probe portion withreinforcing rod inserted can have a stiffness and a column strengthcapable of withstanding axial forces without buckling in excess of 10Newtons and up to 15 Newtons for smaller cross-section devices and up to200 Newtons for larger cross-section devices. It should be understoodthat similarly to the nasolacrimal embodiments described above, themechanical characteristics of the sheath do not appreciably contributeto the mechanical properties of flexibility and column strength of thesheathed probe tool including the reinforcing rod. Thus it is primarilythe mechanical characteristics of the rod engaged tube that determinethe flexibility and column strength of the tool.

Because it is to be introduced into the body, the probe portion 120 canbe made of biocompatible materials.

In the following paranasal sinus embodiments the tube 130 of the ballooncatheter can be made of a material that does not necessarily have thesame flexibility requirements of the nasolacrimal embodiment describedabove. However, the probe portion can be made to have sufficient plasticdeformability to maintain a shape e.g. a bend or curve that is placedupon it by the surgeon. The probe portion can be shaped or bent by thesurgeon as needed during use in one or more of the paranasal sinuses.

Thus, the tube body 130 of the probe portion of a balloon catheter tool131 for use in treating obstructions in one or more paranasal sinusescan have a greater flexibility. That flexibility can be adjusted byengaging a plastically deformable reinforcing rod 170 through the lumen133 of the tube 130 of the balloon catheter tool. The reinforcing rodcan have a luer lock connector 162 that can be attached/screwed into theluer lock 152 on the proximal hub 150 and provide an opening forengaging a fiberoptic cable 157.

The reinforcing rod 170 can extend to the distal extremity 142 of thetube 130 or may be longer and extend out the distal port 135, or beslightly shorter and terminate just inside the distal extremity of thetube. The reinforcing rod may be made of nitinol which is flexible butregains its original shape after the bending force or constraint isremoved. It can thus be easily removed from the balloon catheter tubeafter the desired bend is placed in the tube. Other materials could keeptheir new bent shape and be difficult or impossible to remove from thetube. The reinforcing rod 170 can be made from stainless steel, annealedstainless steel or other metals, plastics or other syntheticbiocompatible materials providing the necessary mechanical properties.

The reinforcing rod 170 may be removed after or temporarily during theplacement of the balloon catheter in order to insert a fiberoptic cable157 with a LED or other light. The light may be white, red or othercolor. The fiberoptic cable may have a luer lock connector (not shown)that can be screwed onto the luer lock on the hub or the lock on thereinforcing rod if present. The LED light will illuminate the sinus tohelp confirm to the surgeon that the catheter has entered the sinus.

As shown in FIG. 11, the reinforcing rod 170 can have semicircular incross section such as a substantially C-shaped cross-section providing acentral axial groove 171 extending the entire length of the reinforcingrod. The fiberoptic light cable 157 can be inserted at the same timewith the reinforcing rod. This gives the surgeon the ability toilluminate the sinus throughout the insertion of the catheter into thesinus.

Alternately, as shown in FIG. 12, the reinforcing rod 175 can havesemicircular in cross section such as a substantially crescent-shapedcross-section, and the fiberoptic cable 176 (which has a circularcross-sectional shape) can be partially inside and partially outside thecrescent-shaped rod. The reinforcing rod and fiberoptic cable can thusbe simultaneously carried within the lumen 177 having a substantiallycircular cross-sectional shape.

The tube 130 can be used to suction material e.g. blood or pus from thesinus. The tube can be used for irrigation of the sinuses or nasalcavity with water or saline, radio-opaque dye, other dyes such asfluorescein.

An important feature of the present embodiment is that the angular shapeof the catheter probe portion 120 need not be preset. In other words,the probe portion can be straight or have any curve or shape when it istaken out of the package by the surgeon. However, the shape of thecatheter can be changed by the surgeon as needed either through plasticdeformation of the tube or the reinforcing rod, or both.

The present embodiment of the balloon 137 is about 6 millimeters (mm) ininflated diameter and 18 mm in length. However, it may be from 2 mm indiameter to 15 mm in diameter and be from 2 mm to 30 mm in length. Avariety of sizes can be provided in kit form to give the surgeonchoices.

The tube 130 may be made of stainless steel, annealed stainless steel,other metals, plastics, silicone or other synthetic materials, plastics,silicone or other synthetic materials with wire mesh or otherreinforcing material within.

The length of the probe portion 120 of the catheter in the presentembodiment is 6 inches (range 2 inches to 20 inches).

The outside diameter of the tube is 1.5 mm (range 0.5 to 5 mm) and wallthickness is 0.005 inch but may vary from 0.001 to 0.3 inch.

The balloon in the ideal embodiment is made of nylon but may be made ofPET or any other biocompatible expandable material.

The above-described surgical tool can be used in a variety of surgicalinterventions involving the treatment of blockages occurring in theparanasal sinuses as explained below.

First proper preparation of the nasal cavity such as a septoplasty,ethmoidectomy, turbinectomy, turbinate infracture, creating a surgicalopening or procedures if indicated are performed by the surgeon.

With respect to the Sphenoid sinus as shown in FIG. 12:

For the sphenoid sinus the probe portion 120 of the catheter tool isusually close to straight i.e. angle of 0 degrees but may be from −90 to+160 degrees.

The sphenoid sinus ostium may be approached and entered directly usingfirst a shaping rod if needed. The shaping rod is bent or curved to thedesired angle. It is placed into the sphenoid sinus ostium. The sphenoidsinus ostium is located inferior to the superior turbinate and betweenthe middle turbinate and nasal septum. In some cases the posteriorinferior portion of the middle turbinate must be resected to allow theshaping rod to gain the sphenoid sinus ostium. In some cases anethmoidectomy must be performed first in order to gain access to thesphenoid sinus and its ostium.

The shaping rod is then removed. The balloon catheter with thestiffening or reinforcing rod in place is bent to the same shape as theshaping rod. In some cases the balloon catheter tube is bent to thedesired curve or angle without using the shaping rod. The ballooncatheter with the stiffening rod is then pushed into the sphenoid sinus.This is usually done with the reinforcing rod (or reinforcing rod andLED light and cable) inside the balloon catheter, but may be done on theballoon catheter alone and then the reinforcing rod or reinforcing rodand LED light and cable placed as a second step. The surgeon theninserts the balloon catheter with reinforcing rod (and LED or otherlight type in some embodiments) through the sphenoid sinus ostium orsurgically prepared opening in the sphenoid sinus into the sphenoidsinus cavity. The location is confirmed by visualization of the LED orother light illuminating the sphenoid sinus. In some cases the surgeonmay move or rotate the catheter to visualize the light movement insidethe sinus. After confirming the proper placement of the balloon catheterthe surgeon connects the inflation port 154 of the hub 150 to theinflation device. The balloon 137 is inflated to nine atmospheres (range1 to 30 atmospheres) for the desired time of 60 seconds (range 1 secondto 5 minutes). The balloon catheter is then deflated. A second inflationor more inflations can be performed if needed. The balloon catheter canbe withdrawn to allow inspection of the ostium or surgical opening ifdesired. It can then be reinserted if needed for additional inflations.Further, the reinforcing rod can be removed and suction or irrigationperformed through the tube 130 if needed.

With respect to the Maxillary sinus as shown in FIG. 13:

A similar process is used for the maxillary ostium and maxillary sinus.The usual angle of the distal balloon section with respect to the moreproximal section of the probe portion 120 is about 120 degrees but mayfrom 50 to 200 degrees.

The middle meatus and maxillary sinus ostium are visualizedendoscopically. A set of shaper rods is provided to the surgeon.Alternatively, the surgeon bends a shaper rod to a desired shape. Theshaper rods are then placed in the middle meatus and gently into themaxillary ostium. If the angle is not optimal then a different shaperrod is obtained. This process is repeated until the ideal angle ofshaper rod that easily goes into the maxillary sinus ostium is obtained.The sinus balloon catheter tube is then bent to the same shape as theideal shaper rod. This is usually done with the reinforcing rod (orreinforcing rod and LED light and cable) inside the balloon catheter,but may be done on the balloon catheter alone and then the reinforcingrod or reinforcing rod and LED light and cable placed as a second step.The surgeon then inserts the balloon catheter with reinforcing rod (andLED or other light type in some embodiments) through the maxillaryostium or surgically prepared opening in the maxillary sinus into themaxillary sinus cavity. The location is confirmed by visualization ofthe LED or other light illuminating the maxillary sinus. In some casesthe surgeon may move or rotate the catheter to visualize the lightmovement inside the sinus. After confirming the proper placement of theballoon catheter the surgeon connects the inflation port 154 of the hub150 to the inflation device. The balloon is inflated to nine atmospheres(range 1 to 30 atmospheres) for the desired time of 60 seconds (range 1second to 5 minutes). The balloon catheter is then deflated. A secondinflation or more inflations can be performed if needed. The ballooncatheter can be withdrawn to allow inspection of the ostium or surgicalopening if desired. It can then be reinserted if needed for additionalinflations. Further, the reinforcing rod can be removed and suction orirrigation performed through the tube 130 if needed.

In some cases the surgeon must push the middle turbinated medially witha periosteal elevator or other instrument to create enough space toplace the shaper rod and subsequently the balloon catheter. In somecases part of the middle turbinate must be excised to create sufficientspace to place the shaper rod and or balloon catheter.

With respect to the Frontal sinus as shown in FIG. 14:

The surgeon may first insert a shaping rod into the frontal sinus. Thesurgeon bends the shaping rod to the desired shape to enter the frontalrecess and nasofrontal duct. The surgeon then shapes the tube to thesame shape as the shaping rod. Alternatively the physician shapes thetube of the balloon catheter without the shaping rod. The shape isusually a gentle curve for the frontal sinus but may be more acute orlarger. He or she then inserts the balloon catheter 131 with reinforcingrod (and LED or other light type in some embodiments) through thestenotic nasofrontal duct or frontal recess or surgically preparedopening in the nasofrontal duct or frontal recess into the sinus cavity.The frontal recess and or frontonasal duct may be entered without othersurgical procedures needed. However, in some cases a partial or completeethmoidectomy is performed first. In some cases the uncinate process isremoved first. In some cases a partial or complete middle turbinectomyis performed first. These procedures are needed in some cases to gainaccess to the frontal recess or nasofrontal duct. The location isconfirmed by visualization of the LED or other light illuminating thefrontal sinus. In some cases the surgeon may move or rotate the catheterto visualize the light movement inside the frontal sinus. Afterconfirming the proper placement of the balloon catheter the surgeonconnects the inflation port 154 of the hub 150 to the inflation device.The balloon is inflated for the desired time to nine atmospheres (rangeone to thirty atmospheres) for (1 second to 5 minutes, ideally 60seconds). The balloon catheter is then deflated. A second inflation ormore inflations can be performed if needed. The balloon catheter can bewithdrawn to allow inspection of the ostium or surgical opening ifdesired. It can then be reinserted if needed for additional inflations.Further, the reinforcing rod can be removed and suction or irrigationperformed through the tube 130 if needed.

The proper angle of the balloon section of the catheter relative to theremainder of the catheter body can be determined by using a small shaperrod that the surgeon bends and places into the ostium or surgicallyprepared opening to determine the needed shape. Alternatively a set ofshape rods may be available. The surgeon uses these to determine thewhich angle is appropriate.

In another embodiment the shaper rods may be made to allow a fiberopticcable with a LED or other light on the end inside the lumen. Theappropriate shaper rod with light may then be placed through the sinusostium, surgically prepared opening or in the sinus recess. The lightilluminates the sinus to demonstrate that it is in the proper location.The shaper rod is then removed. The tube is then shaped or bent by thesurgeon into the desired shape as demonstrated by the chosen shaper rod.The shaper rod may also be part of a set of preshaped rods. The surgeonpicks the rod that is best for the insertion into the sinus and thenbends the tube into the desired shaped. A special device can be used toaid in bending the tube. The shaper rod may in another embodiment have alumen to hold a fiberoptic cable with LED or other light on its distalend. This aids in determining if the shaper rod has penetrated the sinusostium or prepared surgical opening and entered the sinus without a truepassage.

While the preferred embodiment of the invention has been described,modifications can be made and other embodiments may be devised withoutdeparting from the spirit of the invention and the scope of the appendedclaims.

What is claimed is:
 1. A balloon catheter which comprises: an oblongprobe which comprises: an elongated substantially cylindrical hollowbody having a first outer diameter and terminating at a distal extremityand an opposite proximal extremity; said body being made from a hard,semirigid first material; a collar bonded to a portion of said body nearsaid proximal extremity; said collar being made from a hard, semirigidsecond material; said collar having an outer peripheral surface having asecond diameter greater than said first outer diameter; a hand graspablehub comprising a third rigid material, said hub being secured to saidcollar; a flexible sheath coaxially engaged by said body; wherein saidsheath comprises: a proximal end portion secured to said hub; and, adistal end portion comprising a balloon structure; wherein said body hasan axial lumen extending from a proximal opening to a distal port; and,wherein said hub comprises: a first connector leading to a firstpassageway in fluid communication with said distal port; and, a secondconnector leading to a second passageway in fluid communication withsaid balloon structure.
 2. The device of claim 1, wherein said catheterfurther comprises a hub/collar interfacing bond comprising an interfacelayer contacting said collar and said hub, and wherein said interfacingbond further comprises a proximal bead axially bearing against saidcollar.
 3. The device of claim 2, wherein said hub/collar interfacingbond is capable of withstanding an axial sheer load in excess of 10Newtons.
 4. The device of claim 1, wherein said outer peripheral surfacecomprises a surface area increasing structure, and wherein said surfacearea increasing structure comprises a bearing surface having an axialcomponent.
 5. The device of claim 1, wherein said outer peripheralsurface of said collar is shaped to have a plurality of radialirregularities.
 6. The device of claim 1, wherein said second diameteris at least twice as large as said first diameter.
 7. The device ofclaim 1, wherein said sheath has an axial length shorter than an axiallength of said body.
 8. The device of claim 1, wherein said sheath isshaped and dimensioned to allow for a gap between an outer surface ofsaid body and an inner surface of said sheath.
 9. The device of claim 1,wherein said body further comprises: said distal extremity beingblunted; and, said body having a total length between approximately 4and 50 centimeters and an outer diameter between 0.125 and 5.0millimeters.
 10. The device of claim 1, wherein said first material istaken from a group consisting of: stainless steel, bronze, silver,aluminum, titanium, brass, and alloys thereof.
 11. The device of claim1, wherein said first material and said second material are the same.12. The device of claim 1, wherein said probe has a maximumcross-sectional dimension of between about 1.0 millimeter and 4.0millimeters.
 13. The device of claim 1, which further comprises: anelongated reinforcing rod shaped and dimensioned to be inserted intosaid lumen, and wherein said reinforcing rod is further shaped to have asemicircular cross-section, thereby forming an axial groove extending anentire length of said rod; said groove being sized to accommodatepassage of a fiberoptic cable therethrough.
 14. A method for probing theintegrity of a small, tight opening through human tissue into the nasalcavity of a patient, said method comprises: inserting a ballooncatheterization device into the patient's body; wherein said ballooncatheterization device comprises: a metal collared, elongated semi-rigidtubular body having a lumen; a flexible sheath covering a portion ofsaid body; and, a hub secured to a proximal end of said body; tiltingthe device angularly into alignment with said opening; and, pushing thedevice through the opening; wherein said pushing comprises applying anaxial force in excess of 10 Newtons to said hub.
 15. The method of claim14, which further comprises engaging a stiffening rod diametricallysized to engage said lumen and having a length greater than said totallength into said lumen prior to said step of inserting.
 16. The methodof claim 14, which further comprises engaging a stiffening roddiametrically sized to engage said lumen and having a length shorterthan said total length into said lumen prior to said step of inserting.17. The method of claim 14, wherein: said inserting comprises insertingsaid balloon catheterization device through the patient's punctum andcanaliculus down the lacrimal sac; said tilting comprises tilting theballoon catheterization device angularly into alignment with thenasolacrimal duct; and, said pushing comprises pushing the ballooncatheterization device through the nasolacrimal duct down to the nasalcavity.
 18. The method of claim 17, which further comprises injecting anirrigation or tracer fluid through said balloon catheterization devicewhile said device is engaged in said patient's lacrimal system.
 19. Themethod of claim 17, which further comprises suctioning material throughsaid balloon catheterization device while said device is engaged in saidpatient's lacrimal system.
 20. In a semirigid balloon catheter toolincluding an oblong semirigid hollow tube having an axial lumenextending between a proximal opening and a distal port; an improvementwhich comprises: a reinforcing rod shaped to penetrate said lumen; saidrod having a semicircular cross-section, thereby forming an axial grooveextending an entire length of said rod; said groove being sized toaccommodate passage of a fiberoptic cable therethrough.